MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-07-31 for VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES X-SPM 80659998244 manufactured by Wavelight Gmbh Agps.
[4876557]
An opthalmic surgeon reported that the microscope digital markings were "dancing" or "jumping" during intraocular lens (iol) implant in several patients. The digital marking were used in parallel with manual markings and during surgery the surgeon observed a "jump in the axis" of the microscope guidance for marking. The iols were placed according to the manual markings and the postoperative outcome was very good with no residual astigmatism. Additional information has been requested but received to date. This is one of four medical device reports being filed for this facility.
Patient Sequence No: 1, Text Type: D, B5
[11985992]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Additional information has been requested but not received to date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2014-00001 |
| MDR Report Key | 4016851 |
| Report Source | 01,05 |
| Date Received | 2014-07-31 |
| Date of Report | 2014-07-04 |
| Date Mfgr Received | 2014-07-04 |
| Date Added to Maude | 2014-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| Manufacturer G1 | WAVELIGHT GMBH AGPS |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES |
| Generic Name | CAMERA, STILL, MICROSURGICAL |
| Product Code | FTH |
| Date Received | 2014-07-31 |
| Model Number | X-SPM |
| Catalog Number | 80659998244 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH AGPS |
| Manufacturer Address | AM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-31 |